MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER

Model Number AB35SX060120135

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

The patient's age at time of event or dob, gender, and weight are unknown.This information was not available from the facility.During inflation, the balloon ruptured.Recurrence of this malfunction could result in a prolonged intervention.No patient injury reported.Patient information regarding relevant tests/laboratory data or medical history are unknown.Per fda request, this mdr is being reported retrospectively.The stellarex device was discarded by the facility, thus no returned product investigation was performed.Per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.

Event Description

The balloon was inflated at nominal pressure for about 1.5 minutes, then pressure was increased a couple more atm (less than rpb) when the balloon ruptured.After the balloon was removed from the patient, the nurse wiped the balloon clean and connected to an indeflator for inflation.Once inflated, it was noticed that the proximal end had a small tear approximately 1 mm long.The procedure was completed using a different dcb device.No patient injury.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 9513736
• MDR Text Key: 176413067
• Report Number: 3009784280-2019-00733
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00813132023256
• UDI-Public: 00813132023256
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2020
• Device Model Number: AB35SX060120135
• Device Catalogue Number: AB35SX060120135
• Device Lot Number: FHV18A06A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other